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Completed

NCT Number: NCT07329387

Effectiveness of NMES in Swallowing Rehabilitation in Children With CP

Purpose: The aim is to investigate the effectiveness of NMES in the functional and electrophysiological rehabilitation of swallowing difficulties in dysphagic children with cerebral palsy.

Methods: Twenty-six children diagnosed with dysphagia, with a mean age of 7.02±2.40 years, were included in the study and randomly allocated into two groups (NMES,n=16;Sham NMES,n=10). In addition to swallowing rehabilitation, stimulation was applied to the groups. Participants were assessed using the Pediatric Eating Assessment Tool, Penetration-Aspiration Scale, Karaduman Chewing Performance Scale, Swallowing Ability and Function Evaluation and Electrophysiological Evaluation of the Suprahyoid Muscle in four consistencies.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, 40336, Turkey (Türkiye)

About this study

This study has already been completed; however, at the time of the study, registration in the public trial database had not been performed. Since the journal requires a registration number upon submission, we have completed a retrospective registration to fulfill this requirement. The registration reflects the actual study dates and ensures transparency and compliance with publication standard

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients whose relatives provided written informed consent
  • Patients suitable for the planned intervention (assumed from context)

Exclusion criteria

  • History of maxillary, head or neck surgery
  • History of botulinum toxin treatment
  • Structural oropharyngeal abnormality
  • Gastroesophageal reflux disease (GERD)
  • Receiving medical and/or physical therapy for dysphagia
  • Severe cognitive, visual, auditory, or sensory impairments
  • Drug use due to seizure or spasticity
  • Serious pulmonary or cardiac disease
  • Increased bleeding risk

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

For NMES applied to the suprahyoid muscle group, a 80 Hertz frequency, with a transition time of 300-400 microseconds, 40 minutes of Vital Stim application was performed

Sham Neuromuscular Electrical Stimulation

Device

Sham NMES involves applying the electrical stimulation device without delivering therapeutic current, serving as a placebo control in randomized clinical trials

Primary outcomes

  1. Pedi-EAT-10

    Time frame: Baseline (pre-intervention)

    The Pedi-EAT-10 is a caregiver-administered, symptom-based questionnaire designed to screen for signs of oropharyngeal dysphagia in children aged 18 months and older. It consists of 10 items, each rated on a 5-point Likert scale (0 = no problem, 4 = severe problem), assessing observable feeding and swallowing difficulties.Time Frame: Baseline (pre-intervention)

Other outcomes

  1. Pedi-EAT-10

    Time frame: Baseline (pre-intervention) and immediately after the intervention.

    The Pedi-EAT-10 is a caregiver-administered, symptom-based questionnaire designed to screen for signs of oropharyngeal dysphagia in children aged 18 months and older. It consists of 10 items, each rated on a 5-point Likert scale (0 = no problem, 4 = severe problem), assessing observable feeding and swallowing difficulties.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Electrophysiological Investigation of the Effectiveness of NMES Swallowing Difficulty Rehabilitation in Children With Cerebral Palsy

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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